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Services & Solutions

Formulation and Drug Product Development

End-to-End Services for a Wide Variety of Bioconjugates

 

We offer extensive end-to-end services for formulation/process development for a wide variety of bioconjugates. Our team assists from early-stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches.

 

We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.

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Our services include, but are not limited to:

  • Forced degradation studies to identify product degradation pathways
  • High-throughput screening (HTS) for formulation development utilizing biophysical methods
  • Design of Experiment (DOE) to identify the optimal formulations
  • Container and closure selection and integrity testing
  • End-to-end fill process development from drug substance thawing through mixing, filtration, filling, stoppering and capping to final visual inspection
  • Processes development for isolator-based filling systems
  • Pilot scale (non-GMP) fill and lyophilization services for pre-clinical toxicology studies, non-GMP stability studies and scale-down process development
  • Lyophilization cycle development and optimization
  • Fill and lyophilization process scale-up and/or technology transfer, from development to clinical phase or commercial manufacturing
  • In-use compatibility and stability studies to support clinical administration or toxicology studies
  • Stability studies to support formulation and process development under long-term, accelerated or stressed conditions

Formulation development technical platform
Bioconjugate products developability studies, pH/buffer screening, excipients screening, formulation confirmation, forced degradation studies, and clinical in-use studies are conducted to develop the most robust formulations. The lab is equipped with all required instruments including Malvern DSC, Big Tuna, MFI, HIAC, DLS, viscometer, Stunner, Solo VPE, etc.

Lyophilization process technical platform
The lab is equipped with professional experimental instruments, including freeze drying microscope and mDSC, which are used for key thermal parameters characterization (Tg, Tc). The labs also contain a pilot lyophilizer with a variety of advanced PAT technologies consisting of wireless temperature probe, online weighing, MTM, and ControlLyo which support the accurate monitoring of the lyophilization process and guide the establishment of the design space.

Manufacturing process technical platform
Freeze thaw, mixing, filtration, filling process development and in process compatibility studies ensure optimal manufacturability. The lab is equipped with all required instruments including TFF system, mixing system, peristaltic pump, V-max, filling pump, TOC, etc.

 

Additionally, we provide commercial formulations lock and process/device development in preparation for product launches and the concept of QbD is utilized in every process development program.

Our instruments include, but are not limited to:

  • mDSC
  • DLS
  • Rheometer
  • Freeze-drying microscope
  • DSC
  • KF moisture analyzer
  • FTIR microscope
  • Automated screening station
  • High throughput buffer exchange

  • CG-MALS
  • Filling line
  • Lyophilizer
  • Freeze-thaw System
  • MFI
  • HIAC
  • Headspace analyzer
  • Silicone oil distribution analyzer

 

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